Father of Vaccine-Autism Link Said to Have Fudged Data

by John Gever John Gever Senior Editor, MedPage Today
February 11, 2009

LONDON, Feb. 11 -- The British researcher who first linked childhood vaccines to autism has been accused of falsifying data in a 1998 study published in The Lancet.

The Times of London reported Sunday that Andrew Wakefield, M.D., apparently altered clinical findings on eight of 12 children whose cases were the basis for the study.

The allegations follow disclosures in 2004 that Dr. Wakefield's research was partially, and secretly, funded by plaintiffs' lawyers in suits against vaccine makers, and that he had cut procedural corners in the research.

Dr. Wakefield issued a statement denying the new allegations. He also repeated earlier denials that the funding of his research affected his scientific conduct.

The 1998 study was the first to be published in a reputable journal that suggested the MMR vaccine could lead to autism.

Following its publication, rates of childhood vaccination in Britain and elsewhere fell dramatically.

The Times story noted that 1,348 cases of measles were reported in England and Wales in 2008, compared with 56 in 1998.

In the 1998 paper, Dr. Wakefield and colleagues presented evidence that the children had developed intestinal inflammation following vaccination. They suggested that the inflammation released gut proteins into the circulation that eventually migrated to the brain, causing permanent damage reflected in autism symptoms.

But according to the Times, the children's original hospital records differed in important ways from the descriptions in the Lancet paper.

Whereas the paper indicated that, in most cases, symptoms developed within days of vaccination, the records indicated that this was true only for one child, according to the Times.

The children's records also indicated that five of the children had psychosocial problems before vaccination, said the Times, but the paper described them as "developmentally normal."

In addition, the Lancet paper described abnormal intestinal pathology results in the children, but the hospital pathology reports showed no findings of inflammation, the Times report said.

Dr. Wakefield and two of his Lancet co-authors are currently facing misconduct charges before Great Britain's medical licensing board, the General Medical Council, related to the 1998 study and subsequent research.

They are accused of failing to obtain required approvals for the tests they performed on the children and other ethical violations, but the data-manipulation charges reported in the Times are not at question in the hearings.

In his statement, Dr. Wakefield rejected the newspaper's account, contending that the Lancet paper represented the children's conditions accurately. He added that other members of the research group performed the pathology reviews, not he.

"I did not play any part whatsoever in making the microscopic diagnoses of inflammation on any biopsy from any child investigated at the Royal Free Hospital," according to the statement.

The Lancet paper has come under fire before, sparked by an earlier investigation by the same reporter, Brian Deer, who wrote Sunday's Times story.

In 2004, Deer reported that parents of some of the 12 children in the 1998 study had been recruited as potential plaintiffs in a lawsuit against vaccine manufacturers and that the research had been partially funded by Great Britain's Legal Aid Board.

Those allegations led to the current General Medical Council proceeding.

That same year, 10 of the paper's 13 authors -- not including Dr. Wakefield -- retracted the paper's conclusion that the MMR vaccine may cause autism.

Paul Offit, M.D., a pediatrician at Children's Hospital of Philadelphia, and a prominent critic of Dr. Wakefield, said the new allegations cannot really undermine the credibility of the MMR-autism theory because it had already been disproved.

A series of population-based studies have failed to find evidence that vaccines cause autism.

"I'm not sure what more people need to say than that this man and his theory are discredited," Dr. Offit said.

He said there was no longer a scientific controversy about the role of vaccines in autism.

At the same time, he said, the Times report is unlikely to change the minds of those who believe in the link.

"There is not one shred of his hypothesis that has held up," Dr. Offit said.

He counted Dr. Wakefield among the true believers. "I think if you gave him a lie detector test, does MMR cause autism, and he said Yes, he would pass that test. He believes this at the level one holds a religious conviction."

Dr. Wakefield left Britain more than five years ago and now serves as executive director of Thoughtful House, an autism research and treatment center in Austin, Texas.

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